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‘Significant Irish involvement in International leukaemia study’

Irish Medical News on Monday, January 21, 2002
By Hilary Martyn

Ireland’s significant contribution to an international Chronic Myeloid Leukaemia (CML) research study will lead to a growing interest internationally in Ireland as a location for leading-edge haematological research, the Irish Clinical Oncology Research Group (ICORG) has said. This was the first trial set up involving patients from both the Republic of Ireland and Northern Ireland since the organisation became an ‘island of Ireland’ entity, and marked a major achievement for the Group.

The opening of the site where the research was conducted at St James’s Hospital was completed in a record number of only 16 days, with the co-operation of the Irish Medicines Board, and once open had the highest rate of accrual in Europe. Enrolment started in October 2000 and in one year a total of 39 Irish patients were enrolled in the trial, representing 90 per cent of all CML cases in Ireland during the period of the study. Furthermore, the second highest number of referrals for the study came from Northern Ireland, ICORG said. The exceptional patient enrolment was due to the leadership of Prof Shaun McCann at St James’s Hospital, as well as the co-operation of the members of the Irish Haematological Association, according to ICORG. The study was conducted at the St James’s site, with patients referred from six regional health boards, including Northern Ireland.

The objective of the study was to determine the efficacy and safety of a drug called Glivec (formally STI 571) in patients intolerant of/or unresponsive to Interferon alpha, which has been shown by large international studies to be associated with an increase in life expectancy in CML patients. However, due to side-effects many patients discontinue treatment. Results of the Glivec stud, sponsored by the Irish affiliate of Novartis, the manufacturers of Glivec, have shown that given continuously as a single oral daily dose, complete haematological and cytogenetic responses in chronic phase CML have been induced with reduced side-effects, according to ICORG. Plans are in place to establish a national database for CML that would involve the ongoing monitoring of patients, ICORG said.